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Reference ranges are important criteria to evaluating your patient’s laboratory results. Covance provides reference ranges that are age and gender specific and represent a heterogeneous clinical trials patient population. Covance uses a series of flags to represent the meaning of a patient’s test results which fall outside of the reference range.

If a patient’s value triggers a flag, it will print on the laboratory report. Your sponsor may request additional flags. These will also print on the laboratory report.
In order to ensure timely assessment of patient care, regulations require immediate reporting of laboratory values with potentially critical implications for the patient. For all HP and LP flags, Covance calls the investigator site and requires a live voice to receive these values and read back. Notification of other flags are determined by the sponsor of the protocol.

Covance Central Laboratory Services Logistics would like to provide the following information regarding potential courier service delays due to Hurricane Irma.

Investigator Sites in Florida can expect to experience unavoidable service delays by your courier, based on the current or anticipated severe weather in your area. Although contingency plans are in place, some disruption in pickup or delivery service is anticipated by all couriers in Florida.

If your site is located in the impacted area, sample collections should be avoided if at all possible. Contact your normal courier prior to sample collection to confirm if pickup is available in your area.

If you have already drawn samples and your courier is unable to provide sample pickup, please maintain your specimens at the designated transport temperature until the next available pickup. Maintain ambient samples at ambient temperature, frozen samples in a frozen state in a freezer or on dry ice, refrigerated samples should be kept refrigerated.

Couriers will resume normal service schedules as soon as the situation allows. You can obtain further courier service weather updates by visiting your courier’s websites (ups.com or fedex.com).

If you have any questions regarding this information please contact Covance Investigator Support at 866-762-6209.

If a data revision has been requested for change of collection date, time, weight, visit, etc., the request may take up to 8 to 10 business days.

Once the change is complete, a fax will be sent to the site reporting the change has been made. A new report will not be sent. If a new report is needed please call Covance at the number listed for your area in the Contacts’ section of the laboratory manual.

There is a new and improved website just for you! The new Investigator Services website is up and running and contains numerous resources for investigator sites.

We gathered all the resources that sites might want and listed them so you could easily find what you needed on one page. What’s available: Everything from training videos, to centrifuge instructions, to contact numbers and much more.

Go to Covance.com to see the new page and bookmark it or add it to your favorites so you will have easy access to these resources.

These certifications are only updated in the investigator manual once per year during an annual Standard Page Update period. The link currently listed in the investigator manual is no longer in operation.

In order to process online kit orders correctly without any query from Covance, it is important to enter the correct kit name on the order form. You can locate the kit name in the Central Laboratory Services Laboratory Manual. The official kit name is listed under the Laboratory Visit Schedule.